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Understanding Validation Requirements of Rapid Methods

Written by Rapid Micro Biosystems | Feb 20, 2014 1:30:00 PM

When companies evaluate rapid methods for use in their microbial quality control testing, one area that can often cause confusion is the validation requirements of the various methods. For example, methods that are growth-based have different validation requirements to methods that would be considered alternative, and within the alternative methods there are differences based on the scientific method employed. The recent release of the newly revised PDA Technical Report 33, “Evaluation, Validation and Implementation of New Microbiological Testing Methods,” is an excellent resource for detailed guidance on preparing the business to implement and validate a rapid method.

Automated, growth-based methods such as The Growth DirectTM System allow users to automate the tasks they already perform by hand, streamlining their existing workflows and cutting out a great deal of hands-on work. These types of methods can be classified as “automated compendial,” since they simply automate the existing method and provide results in colony forming units (CFUs). In contrast, some alternative RMM technologies involve entirely new processes and additional steps. These changes can impact training plans and SOPs and increase the validation requirements.

Whatever method is selected, it must be validated before moving into routine use. Among other stakeholders, the validation process requires involvement of quality assurance personnel and external regulatory agencies if a license change is required. The following are some of the processes involved in validating growth-based and alternative rapid methods.

Alternative Method Validation

Because many alternative methods deviate significantly from the traditional method, the validation requirements often include not only accuracy and precision but also specificity, linearity, range and robustness. An additional challenge with some alternative methods is reporting in measurements other than CFUs, creating an extra effort to equate the results to the traditional method. These can require more time and resources for manufacturers to validate the method. Alternative technologies may use different growth mediums, which must be shown to produce levels of growth similar to traditional agars. These additional testing requirements can drastically lengthen the time and money manufacturers must spend before they can apply these new technologies in their QC labs.

Growth-Based Validation

Since automated growth-based methods simply automate the compendial method, they require less validation steps. According to the PDA's TR33 document, technologies that are considered automated traditional or compendial need to be validated for accuracy and precision as part of the activities listed below.

For a technology like the Growth Direct™ System, this means that the validation process would involve the following steps:

  • Installation and Operational Qualification (IOQ): Ensures that all systems are installed correctly and the equipment operates appropriately.
  • Performance Qualification (PQ): Verifies the systems' performance compared to the compendial method using a variety of standard organisms.
  • Method Suitability: Validates the new method against the specific product of interest. This step ensures that the product of interest does not exhibit any inherent characteristics that would interfere with the new method and that the new method produces results comparable to the traditional method. 

Ongoing Support

For Growth DirectTM System users, validation can be streamlined with the help of experienced product experts. Rapid Micro Biosystems personnel are available during every step of the system's installation and validation, providing training, documentation and support to both quality control and quality assurance personnel.

Straightforward validation is just one of the benefits of The Growth DirectTM System. To learn more about how a growth-based system can improve your quality control environment, download the free guide, 4 Benefits of Automated Rapid Detection & Enumeration today.